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    Summary
    EudraCT Number:2020-001786-36
    Sponsor's Protocol Code Number:ILIAD-7-UK-Cohort
    National Competent Authority:UK - MHRA
    Clinical Trial Type:EEA CTA
    Trial Status:GB - no longer in EU/EEA
    Date on which this record was first entered in the EudraCT database:2020-04-15
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedUK - MHRA
    A.2EudraCT number2020-001786-36
    A.3Full title of the trial
    Recombinant InterLeukin-7 (CYT107) to Improve clinical outcomes in lymphopenic pAtients with COVID-19 infection “ILIAD 7 trial”
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study of investigational medicinal product of CYT107 in patients with COVID-19 infection who have low number of lymphocytes in their blood (ILIAD 7 trial)
    A.3.2Name or abbreviated title of the trial where available
    ILIAD
    A.4.1Sponsor's protocol code numberILIAD-7-UK-Cohort
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorRevImmune SAS France
    B.1.3.4CountryFrance
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportRevImmune SAS France
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationRevImmune SAS France
    B.5.2Functional name of contact pointMichel Morre
    B.5.3 Address:
    B.5.3.1Street Address15 rue Taitbout
    B.5.3.2Town/ cityParis
    B.5.3.3Post code75009
    B.5.3.4CountryFrance
    B.5.4Telephone number33603357060
    B.5.6E-mailmmorre@revimmune.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.1.2Country which granted the Marketing AuthorisationUnited Kingdom
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameCYT107
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboSolution for injection
    D.8.4Route of administration of the placeboIntramuscular use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Lymphopenia and T cell exhaustion in COVID-19 patients
    E.1.1.1Medical condition in easily understood language
    COVID-19 patients whose their number of lymphocytes in their blood is low
    E.1.1.2Therapeutic area Diseases [C] - Virus Diseases [C02]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    The primary objective of the Study is to improve the absolute lymphocyte count (ALC) of lymphopenic (ALC≤700/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever comes first.
    E.2.2Secondary objectives of the trial
    a) To obtain “clinical improvement” as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD
    b) To determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD
    c) To compare the incidence of grade 3-4 adverse events for CYT107 versus placebo through day 45
    d) To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45
    e) To compare the effect of CYT107 versus placebo on the length of hospitalization
    f) To compare the effect of CYT107 versus placebo on the length of stay in ICU
    g) To compare the effect of CYT107 versus placebo on readmissions to ICU
    h) To compare the effect of CYT107 versus placebo on organ support free days
    i) To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45
    j) To assess the impact of CYT107 on all-cause mortality through day 45
    AND objectives k, l, m and n

    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. A written, signed informed consent, or emergency oral consent, by the patient or the patient’s legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing Study participation
    2. Men and women aged ≥ 25 – 80 (included) years of age
    3. Hospitalized patients with two absolute lymphocyte count (ALC) ≤ 700 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION:
    The FIRST time point should not be performed earlier than 48 hours after Hospitalization, thus first test dose can’t be administered before 72 hours after hospitalization (From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient’s clinical status)
    4. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >4L per minute nasal cannula or greater to keep saturations >90%, non-invasive positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for respiratory failure
    5. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site
    6. Patient with medical insurance or government support
    E.4Principal exclusion criteria
    1. Pregnancy or breast feeding;
    2. Refusal or inability to practice contraception regardless of the gender of the patient;
    3. ALT and/or AST > 5 x ULN
    4. Known, active auto-immune disease;
    5. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing;
    6. Patients with past history of Solid Organ transplant.
    7. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.
    8. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours
    9. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized
    10. Patients with baseline Rockwood Clinical Frailty Scale ≥ 6.
    11. Patients under guardianship
    E.5 End points
    E.5.1Primary end point(s)
    An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).
    E.5.1.1Timepoint(s) of evaluation of this end point
    Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks
    E.5.2Secondary end point(s)
    a) The time to clinical improvement to determine if CYT107 will improve the clinical status of hospitalized COVID-19 patients as measured by clinical improvement score (Cao, NEJM 2020). Comparative analysis of improvement time course to be performed for CYT107 group vs placebo.
    b) The decrease of SARS-CoV-2 viral load from measurements at baseline and days of treatment dose 4 and dose 5, Day 21 and Day 30 or HD (whichever occurs first). Viral load is measured from nasal or pharyngeal swabs (plus endotracheal secretions if accessible). The time course of the viral load drop will be compared between the CYT107 group and the placebo group.
    c) Incidence and scoring of all grade 3-4 adverse events through Day 45 (using CTCAE Version 5.0 to assess severity)
    d) Incidence of secondary infections based on pre-specified criteria as adjudicated by the Secondary Infections Committee (SIC) through Day 45
    e) Number of days of hospitalization during index hospitalization (defined as time from initial Study drug treatment through HD)
    f) Number of days in ICU during index hospitalization
    g) Readmissions to ICU through Day 45
    h) Organ support free days (OSFDs) during index hospitalization (This includes ventilator assistance free days.)
    i) Number of readmissions to the hospital through Day 45
    j) All-cause mortality through Day 45
    k) Absolute numbers of CD4+ and CD8+ T-cell counts at timepoints indicated on the Schedule of Activities (SoA) through Day 30 or HD
    l) Examination and evaluation of effect of CYT107 on immune biomarkers: monocyte HLA-DR expression at SoA timepoints
    m) Track and evaluate other known biomarkers of inflammation, CRP, D-dimer, and Ferritin, at SoA timepoints
    n) Evaluate improvement of the NEWS2 score value
    E.5.2.1Timepoint(s) of evaluation of this end point
    Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Yes
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned10
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA20
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Italy
    Spain
    United States
    E.8.7Trial has a data monitoring committee Yes
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    LVLS
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months4
    E.8.9.1In the Member State concerned days
    E.8.9.2In all countries concerned by the trial months6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 38
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 10
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    A written, signed informed consent or emergency oral consent can be given by the patient or the patient’s legally authorized representative (LAR). The patient will be re-consented as soon as possible
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state48
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 200
    F.4.2.2In the whole clinical trial 200
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Patients who complete the study will be treated by their physician in accordance with the clinical routine of the respective site and upon further discretion of the responsible physician. The IMP will not be made available for continuation of treatment after the patient has completed the study. The Sponsor will not provide their standard of care medications.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-04-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-05-06
    P. End of Trial
    P.End of Trial StatusGB - no longer in EU/EEA
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